510(k) K222212
K222212 is an FDA 510(k) premarket notification submitted by Ivwatch, LLC for the device "ivWatch Model 400". The FDA issued a decision of Substantially Equivalent on Aug 24, 2022. The device falls under product code PMS (Peripheral Intravenous (Piv) Infiltration Monitor), a Class II device regulated under 21 CFR 880.5725. Ivwatch, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 24, 2022
- Date Received
- Jul 25, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Peripheral Intravenous (Piv) Infiltration Monitor
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type
Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations.